Brain Implants Near Milestone

SAN JOSE, Calif. — The product Steve Archer started work on 14 years ago is just about to hit the market -- he hopes.

The NeuroPace RNS is the first implant to listen to brain waves and autonomously decide when to apply a therapy to prevent an epileptic seizure. It was developed by a company with a staff of less than 90 people, only about 30 on the core electronic, mechanical, and software engineering teams.

Maintaining a lean staff was a conscious decision of managers who have raised $215 million to date and knew the project would take a long time to pass regulatory approvals. "The joke is we have been two years away from an FDA clearance for about a decade," said Archer.

The FDA now says the company is very close to getting a green light, though it is not giving any specific dates. Indeed, an FDA representative was calling the company despite the recent government shutdown to work out details.

"There are a lot of really sexy engineering fields out there that let you make a lot of money, but the medical sector is very regulated so what takes a few weeks to design in a hard drive takes years in medical," Archer said.

On the other hand, "there's a certain feeling when something you personally designed is walking around inside a great number of people -- you feel like it sure better work, but it's more than that," Archer said, recalling some of the 256 epilepsy patients so far who have been able to lead more normal lives due to receiving the implant in clinical trials.

Archer shows a prototype RNS implant in a skull.

The work holds promise of advancing brain science, too. For instance, NeuroPace already has discovered patients can have hundreds to thousands of pre-seizure events every day.

"No one else is recording ambulatory brain wave activities from epileptic patients to the extent we are," Archer said. "We have the world's largest library of such recordings and that's a tremendous resource for all sorts of research -- the opportunity is huge," he said.

Indeed, some say today's deep brain implants are in a stage of development similar to cardiac devices in the early 1980s. They may spawn families of systems addressing a wide variety of neurological disorders.

Interesting blog, I had to go back to neuropace webpage to see what kind of seizures they are targeting. Petit mal and grand mal, are not current used medical terms for seizures, the classification we use now are partial, generalized and unclassified. The target of these devices are Disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures that are not controlled with the current medication.

I this will be something interesting specially for pediatric patients that have neurological syndromes that include these type of seizures and controlling that, could lead to a more healthy/regular style of life. Assuming this is only for adult patients, I am waiting to see what it will offer for the little ones.

Having recentlhy witnessed a grand mal seizure from someone close, I'm happy to see this. At the same time, I think the extended approval period isworthwhile. From what I understand, the current state of anti-seizure drugs are very effective. I'd be curious to know under what circumstances the implants are more or less effective than the state of the art drugs... both are invasive but in different ways.

This is exciting news after 14 years of hard work. The first implant to listen to brain waves and autonomously decide when to apply a therapy to prevent an epileptic seizure will indeed improve the life of many people. I cannot wait to hear more. Hope there will be a follow-up article with more detail information once it hit the market.

If I understand Nearfield comunications and inductive loop communications they limit the potential range of the medical link to a safer distance -- now these type links need to be bullet proofed vs in-channel over an assumed good link, type attack -- probably harder and more expensive than meets the eye but this may be the best option.

Evrything developed today has the hackers threat looming large on it. So why not make such devices stand alone with a physical key access.

Hackers need some connection, some port thorugh which to gain access to a system. But if you make a system such as this implant a stand aone thing then it could remain secure from the hackers and only accessible to the attending doctor or the patient himself.

>> The way the device is fit into the skull a bit scary to me, so I believe in future devices will be more compact, thin and light weight

You are correct. I hope the era of nano-electronics will come when some of these advances can be implemented in a more robust way. Footprint is a key factor in this type of product. Very commendable feat and hope they can nail this with FDA approval to help people around the world